Associate Director, Commercial Manufacturing & Packaging

Travere Therapeutics; New York (NY); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Retirement plans

Paid time off

Job summary

Travere Therapeutics, based in San Diego with remote work options, is seeking an Associate Director of Commercial Manufacturing. You will lead external manufacturing networks, drive process validation and tech transfer, and ensure continuous supply of commercial products.

The role requires a Bachelor’s in a relevant field and 8+ years in pharmaceutical manufacturing, including multiple dosage forms. Travel up to 10% domestically and internationally is expected.

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline.
• 8+ years of progressive experience in pharmaceutical manufacturing and packaging shop floor activities.
• Manufacturing experience with multiple dosage forms, including oral solid dosage forms.

Responsibilities

• Direct and coordinate manufacturing activities at CMOs for commercial drug products.
• Establish and maintain manufacturing schedules based on internal sales forecasts and S&OP decisions.
• Verify suitability, qualification and validation of processes at CMOs for drug product.
• Provide manufacturing support, troubleshooting, on internal and external project teams.
• Maintains up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical drug product manufacturing and packaging.
• Represent commercial manufacturing for technical due diligence, CMO selection, qualification, contracting support, and manufacturing-network strategy.
• Author/edit technical reports on a variety of manufacturing-related subjects as needed.
• Assist management during regulatory inspections and internal, and external audits.
• Assist with the development of CMC sections of regulatory submissions.

Skills

Process validation

Technology transfer

Project management

Regulatory compliance

Education

Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline

Job description

Department:

106800 Technical Operations

Location:

San Diego, USA- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Position Summary:

The Associate Director, Commercial Manufacturing is accountable for the strategy, oversight, and execution of commercial drug product manufacturing and packaging activities across Travere's external manufacturing network. This role leads manufacturing planning, CMO governance, process validation, technology transfer, operational performance, and supply-risk management to ensure a reliable, compliant, and uninterrupted supply of commercial products. The Associate Director partners with Supply Chain, Quality, Regulatory Affairs, Technical Operations, and Commercial stakeholders to translate business forecasts and product strategies into executable manufacturing plans and to provide senior management with recommendations regarding capacity, resources, risk, and external manufacturing strategy.

Responsibilities:

• Direct and coordinate manufacturing activities at CMOs for commercial drug products to ensure uninterrupted market supply.
• Establish and maintain manufacturing schedules based on internal sales forecasts and Sales & Operations Planning meeting decisions; assess capacity, inventory, and supply risks and lead the development of mitigation and contingency plans.
• Verify suitability, qualification and validation of processes at Contract Manufacturing Organizations (CMO) for drug product.
• Provide manufacturing support, troubleshooting, on internal and external project teams.
• Maintains up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical drug product manufacturing and packaging.
• Represent commercial manufacturing for technical due diligence, CMO selection, qualification, contracting support, and manufacturing-network strategy.
• Author/edit technical reports on a variety of manufacturing-related subjects as needed.
• Assist management during regulatory inspections and internal, and external audits.
• Assist with the development of CMC sections of regulatory submissions.
• Additional duties assigned as needed.

Education/Experience Requirements:

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline required. Equivalent combination of education and applicable job experience may be considered.
• 8+ years of progressive experience directly leading pharmaceutical manufacturing and packaging shop floor activities including process troubleshooting and optimization activities required.
• Manufacturing experience with multiple dosage forms desired, including oral solid dosage forms.

Additional Skills/Experience:

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Expert knowledge in process validation and technology transfer procedures.
• Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills.
• Excellent decision-making and collaboration skills with strong attention to detail.
• Ability to travel 10% domestically and internationally.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Total Rewards Offerings

Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.

Benefits:

Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation:

Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range:

$150,000.00 - $195,000.00

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.